collect DermacinRx Lidotral Generic Name: lidocaine hydrochloride Dosage Form: cream Side Effects Dosage Professional Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. DermacinRx Lidotral Description Lidotral (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Ingredients: Each gram of Lidotral 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic. Slideshow Upcoming Joint Replacement? Your 13 Most Common Questions Answered DermacinRx Lidotral - Clinical Pharmacology Mechanism of Action: Lidotral 3.88% Cream releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritations and to provide a favorable environment for healing. Pharmacokinetics: Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation of the liver. Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage, and conjungation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexlidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration and the fraction bound decreases with increasing concentration. At concentration of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid-glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity. INDICATIONS For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation. Contraindications Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Warnings For external use only. Not for ophthalmic use. Precautions If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral (Lidocaine HCl) 3.88% Cream should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted. Use in Pregnancy: Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother. Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition. Adverse Reactions During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. DermacinRx Lidotral Dosage and Administration Apply a thin film to the affected area two or three times daily or as directed by a physician. How is DermacinRx Lidotral Supplied DermacinRx Lidotral (Lidocaine HCl) 3.88% Cream 3 oz (85 g) tube - NDC 59088-371-07 KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Store at 20 -25 C (68 -77 F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured by: PureTek Corporation, San Fernando, CA 91340 Rev. 37744 10/15 PRINCIPAL DISPLAY DermacinRx Lidotral (Lidocaine HCl) 3.88% Cream - 3 oz (85 g) carton DERMACINRX LIDOTRAL lidocaine hydrochloride cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-371 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 38.8 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM ACETATE POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL GLYCERIN METHYLPARABEN MINERAL OIL PETROLATUM PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS Packaging # Item Code Package Description 1 NDC:59088-371-07 1 TUBE in 1 CARTON 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/03/2015 Labeler - PureTek Corporation (785961046) Establishment Name Address ID/FEI Operations PureTek Corporation 785961046 manufacture(59088-371) Revised: 11/2015 PureTek Corporation Next Interactions Print this page Add to My Med List More about DermacinRx Lidotral (lidocaine topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical anesthetics Consumer resources Professional resources Wound Debridement Kit (FDA) Other brands: Lidocaine Viscous , Xylocaine Jelly , Xylocaine Topical , Astero , ... +15 more Related treatment guides Local Anesthesia Pain Pruritus FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Drug Class Topical anesthetics Related Drugs topical anesthetics lidocaine topical , Lidoderm , Emla , cocaine topical Pain tramadol , acetaminophen , Tylenol , naproxen , oxycodone , aspirin , ibuprofen , More... 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